Medication Therapy Management With Pharmacogenetic Testing

April 17, 2015 updated by: Duke University

Assessing Feasibility and Utility of Enhancing Medication Therapy Management With Pharmacist-Delivered Pharmacogenetic Testing

This study aims to investigate the benefit and feasibility of providing pharmacogenetic (PGx) testing as part of a standard medication therapy management (MTM) session for patients taking multiple medications, a high-risk population for adverse drug reactions and non-response. Research participants will attend two MTM sessions and undergo PGx testing to inform the MTM plan. Participants will also complete 2 surveys pre and post-MTM/PGx testing. Data analysis will assess the impact of MTM/PGx testing on recommendations for drug dosing, clinical outcomes, patient satisfaction, and feasibility of service delivery. Safety issues are minimal with the primary risks being associated with loss of confidentiality, typical discomfort associated with acquiring blood samples, and genetic discrimination.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27713
        • Duke Health Center at Southpoint

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • currently prescribed 3 medications, one of which must be simvastatin or clopidogrel
  • 18 years of age or older
  • English speaking
  • patients of Mahesh Patel or William Kraus at Duke Southpoint Clinic

Exclusion Criteria:

  • if patient has ever had MTM or PGx

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MTM and PGx
Participants attend two MTM sessions and have PGx testing
Other: MTM with PGx
Patients will attend MTM sessions and receive PGx testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction with MTM and PGx
Time Frame: 3 months after completion of MTM2
This will be assessed by a quantitative survey
3 months after completion of MTM2
Change in clinical biomarkers associated with drug therapy
Time Frame: baseline and 2 months
Changes in biomarkers before and after MTM/PGx will be measured. Biomarkers of study group will be compared to chart-review control
baseline and 2 months
Number of recommended drug selection/dosing adjustments
Time Frame: approximately 9 months
Drug selection/doing changes will be compared between study population and chart-review controls
approximately 9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Physician time to perform MTM and PGx
Time Frame: end of study, approx. 9 months
end of study, approx. 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Susanne Haga, PhD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

October 23, 2013

First Submitted That Met QC Criteria

October 23, 2013

First Posted (Estimate)

October 28, 2013

Study Record Updates

Last Update Posted (Estimate)

April 20, 2015

Last Update Submitted That Met QC Criteria

April 17, 2015

Last Verified

October 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • Pro00048123

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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